Insmed (INSM) Q1 2025 Earnings Call May 08, 2025 08:00 AM ET Speaker0 Thank you for standing by. My name is Amy, and I will be your conference operator for today. At this time, I would like to welcome everyone to the Insmed First Quarter twenty twenty five Financial Results Call. All participants have been placed in a listen only mode. After the speakers' remarks, we will conduct a question and answer session. It is now my pleasure to turn the call over to Brian Dunn. You may begin. Speaker1 Thank you, Amy. ...

May 8, 2025 First-Quarter 2025 Earnings Presentation 1 Forward Looking Statements This presentation contains forward-looking statements that involve substantial risks and uncertainties. "Forward-looking statements," as that term is defined in the Private Securities Litigation Reform Act of 1995, are statements that are not historical facts and involve a number of risks and uncertainties. Words herein such as "may," "will," "should," "could," "would," "expects," "plans," "anticipates," "believes," "estimates ...

Exhibit 99.1 Insmed Reports First-Quarter 2025 Financial Results and Provides Business Update —ARIKAYCE® (amikacin liposome inhalation suspension) Total Revenue of $92.8 Million for the First Quarter of 2025, Reflecting 23% Growth Over the First Quarter of 2024— —NDA for Brensocatib in Patients with Bronchiectasis Remains on Track, with a PDUFA Target Action Date of August 12, 2025— —Phase 2b Study of TPIP in Patients with PAH Completed; Topline Data Expected in June 2025— —Enrollment Completed for Phase 2b ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number 000-30739 INSMED INCORPORATED (Exact name of registrant as specified in its charter) Virginia 54-1972729 (State or other jurisdictio ...

The market expects Insmed (INSM) to deliver a year-over-year decline in earnings on higher revenues when it reports results for the quarter ended March 2025. This widely-known consensus outlook is important in assessing the company's earnings picture, but a powerful factor that might influence its near-term stock price is how the actual results compare to these estimates.The earnings report, which is expected to be released on May 8, 2025, might help the stock move higher if these key numbers are better tha ...

About Insmed Insmed Incorporated is a people-first global biopharmaceutical company striving to deliver first- and best-in- class therapies to transform the lives of patients facing serious diseases. The Company is advancing a diverse portfolio of approved and mid- to late-stage investigational medicines as well as cutting-edge drug discovery focused on serving patient communities where the need is greatest. Insmed's most advanced programs are in pulmonary and inflammatory conditions, including a therapy ap ...

Core Insights - Insmed Incorporated announced positive results from the pivotal phase 3 ASPEN study of brensocatib, demonstrating a statistically significant reduction in pulmonary exacerbations in patients with non-cystic fibrosis bronchiectasis [1][2] - Brensocatib is currently under Priority Review with the U.S. FDA, with a target action date of August 12, 2025 [5] Study Results - The ASPEN study is the largest clinical trial ever conducted in bronchiectasis, involving 1,680 adult patients and 41 adolescent patients across 391 sites in 35 countries [6][7] - The annualized rate of pulmonary exacerbations was significantly lower in the brensocatib groups: 1.02 for 10 mg, 1.04 for 25 mg, compared to 1.29 for placebo, with rate ratios of 0.79 (P=0.004) and 0.81 (P=0.005) respectively [2][3] - Both dosage strengths of brensocatib also met secondary endpoints, including prolonging time to first exacerbation and increasing the proportion of patients remaining exacerbation-free [3] Safety and Tolerability - Brensocatib was well-tolerated, with treatment-emergent adverse events (TEAEs) occurring in at least 5% of patients, including COVID-19, nasopharyngitis, cough, and headache [4] Market Potential - Approximately 500,000 patients in the U.S., 600,000 in the EU5, and 150,000 in Japan are diagnosed with bronchiectasis, highlighting a significant unmet medical need [7] - Brensocatib has the potential to be the first approved therapy for bronchiectasis and the first DPP1 inhibitor, addressing a range of neutrophil-mediated inflammatory diseases [5][8] Company Overview - Insmed is a global biopharmaceutical company focused on delivering first- and best-in-class therapies for serious diseases, with a diverse portfolio of investigational medicines [9][10]

Core Insights - Insmed Incorporated will present 11 abstracts from its respiratory portfolio at the ATS 2025 International Conference, focusing on the efficacy and safety of brensocatib and health outcomes in patients with Mycobacterium Avium Complex lung disease [1][2][26] Group 1: Company Overview - Insmed is a global biopharmaceutical company dedicated to developing first- and best-in-class therapies for serious diseases [1][26] - The company is advancing a diverse portfolio of approved and investigational medicines, particularly in pulmonary and inflammatory conditions [26][27] Group 2: Research and Development - The Phase 3 ASPEN study is the largest clinical trial in bronchiectasis to date, evaluating brensocatib's performance across various patient subgroups [2][6] - New health economics and outcomes research related to MAC lung disease will also be presented, highlighting treatment patterns and health status improvements [1][3] Group 3: Upcoming Presentations - Presentations will include analyses of treatment patterns in non-cystic fibrosis bronchiectasis and healthcare resource utilization for MAC lung disease [3] - Specific sessions will focus on the efficacy of brensocatib in patients with different backgrounds, including those with eosinophilic bronchiectasis [3][9]

Core Insights - Insmed's international operations are crucial for assessing its financial resilience and growth prospects, especially in the context of a global economy [1][2][3] Financial Performance - For the quarter ended December 2024, Insmed reported total revenue of $104.44 million, marking a 24.8% increase year over year [4] - Japan contributed $30.7 million, accounting for 29.39% of total revenue, with a slight miss of -0.07% against analyst expectations [5] - Revenue from Europe and the rest of the world was $5.9 million, representing 5.65% of total revenue, also missing projections by -0.51% [6] Future Projections - Analysts expect Insmed to report total revenue of $94.72 million in the current fiscal quarter, indicating a 25.5% increase from the prior year [7] - For the full year, total revenue is projected at $467.34 million, reflecting a 28.5% increase from the previous year, with Japan and Europe expected to contribute $116.82 million and $24.1 million, respectively [8] Market Dynamics - Insmed's reliance on international markets presents both opportunities and challenges, necessitating close monitoring of revenue trends for accurate future projections [9][10]

Core Viewpoint - The FDA has reaffirmed that Insmed's New Drug Application (NDA) for brensocatib is under Priority Review, with a target action date set for August 12, 2025, indicating a significant step towards potential approval for treating bronchiectasis [1][2]. Company Overview - Insmed Incorporated is a global biopharmaceutical company focused on developing first- and best-in-class therapies for serious diseases, with a diverse portfolio of approved and investigational medicines [5][6]. - The company is recognized as one of the best employers in the biopharmaceutical industry, having been named the No. 1 Science Top Employer for four consecutive years [6]. Product Information - Brensocatib is an investigational small molecule, oral, reversible inhibitor of dipeptidyl peptidase 1 (DPP1), aimed at treating bronchiectasis and other neutrophil-mediated diseases [4]. - The NDA for brensocatib is based on data from the ASPEN study, the largest Phase 3 study conducted in patients with bronchiectasis, which highlights its potential to be the first approved treatment for this condition [2][4]. Disease Context - Bronchiectasis is a chronic lung disease affecting approximately 500,000 patients in the U.S., 600,000 in the EU5, and 150,000 in Japan, with no approved therapies specifically targeting the disease in these regions [3]. - The disease is characterized by permanent dilation of the bronchi due to infection and inflammation, leading to symptoms such as chronic cough and shortness of breath [3].